Opioid Safe Use and Handling Guide

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Helpig Patiets Safely Use Opioids Opioid Safe Use ad Hadlig Guide For additioal resources ad iformatio, visit the C.A.R.E.S. Alliace at www.caresalliace.org A Resource for Patiets Sposored by Because I have a resposibility to kow the risks. COVIDIEN, COVIDIEN with logo, ad Covidie logo are U.S. ad / or iteratioally registered trademarks of Covidie AG. 2010 Covidie. CA-015 Jue 2010. Prited i USA. Covidie 675 McDoell Blvd Hazelwood, MO 63042 www.covidie.com

Key Terms Abuse - Use of a medicatio for a omedical purpose such as alterig oe s state of cosciousess (ie, gettig high). Addictio - A disease i which people crave or caot cotrol use of a drug, or cotiue usig a drug eve though they kow it is ot good for them. Misuse - Use of a medicatio prescribed for a legitimate medical purpose i ways other tha as directed or idicated. Opioid - A kid of medicatio that is ofte used to treat pai. Opioids are very strog medicies that are dagerous if used i ways other tha as directed or by people who do ot have a prescriptio. Opioid Tolerace - A chage i your body from takig opioid pai medicie for a period of time, causig oe or more effects of the medicie to be reduced. For example, tolerace may mea you have to take more opioid pai medicie to get the same pai relief. Tolerace is ot the same as addictio. Overdose - A life-threateig state that occurs whe a perso takes more of a medicatio tha his or her body ca hadle. Table of Cotets Itroductio... 2 Uderstadig the Risk of Overdose... 3 Uderstadig the Risk of Abuse... 5 Uderstadig the Risk of Addictio... 7 Talkig With Your Healthcare Provider... 8 How to Protect Yourself ad Your Family... 9 Examples of Exteded-Release ad Log-Actig Opioids...11 Glossary of Importat Terms...12 Refereces...13 Safe Use ad Hadlig Card...15 My Meds Card...16 Itroductio Your healthcare provider has determied that a opioid aalgesic (strog pai reliever) is a appropriate medicie to treat your pai. Before you start takig this medicie, you should uderstad how to safely use ad hadle opioid pai medicies so that the beefits outweigh the risks. This documet does ot take the place of speakig to your healthcare provider or readig the product Medicatio Guide. The Medicatio Guide cotais the most importat safety iformatio. Always read the Medicatio Guide that accompaies your medicie. 1 2

Uderstadig the Risk of Overdose Opioid aalgesics are strog pai medicies that ca cause life-threateig breathig problems ad some opioids ca cause life-threateig heart problems. If prescribed ad used correctly, opioid pai medicies ca safely be used to maage your pai. However, if used i ay way other tha istructed by your healthcare provider or if used by a perso for whom they were ot prescribed, these medicies ca cause a overdose that could lead to life-threateig breathig problems. Quick Facts Accidetal use by a child is a medical emergecy ad ca result i death. 1, 2, 5 If a child accidetally takes opioid pai medicie, get emergecy help right away, eve if the child is ot experiecig ay side effects Takig opioid pai medicie whe it has ot bee prescribed for you ca cause a overdose ad lead to life-threateig breathig problems, especially i childre 1 Thousads of people die each year due to overdose as a result of prescriptio opioid abuse or misuse 4 1, 2, 3 A overdose ca occur if opioid pai medicie is ot take properly Tips to Prevet Overdose 1, 2, 3 Take your opioid pai medicie exactly as prescribed or directed Do ot take more tha your prescribed daily dose Never use alcohol while takig opioid pai medicies Ask your healthcare provider before you take other medicies Keep opioid pai medicies i a safe place away from childre ad from ayoe for whom they have ot bee prescribed Never share your opioid pai medicie Dispose of your opioid pai medicie as soo as it is o loger eeded 6, 7 (See Safe Disposal, p. 10) Call 911 immediately i case of overdose or accidetal use Special Cosideratios for Exteded-Release Opioids * May pai medicies should be take oly if you are already regularly usig opioid pai medicies aroud the clock ad your body is used to takig these medicies. This meas you are opioid tolerat. If you have ay questios talk to your healthcare provider or pharmacist Certai, usually exteded-release, opioid pai medicies should oly be take for log-term pai ad should ot be used to treat pai that you have oly oce i a while or that is expected to last for oly a short time Do ot break, chew, crush, or dissolve tablets or capsules that are meat to be swallowed whole, do ot sort, iject, or ihale tablet or capsule cotets, ad do ot use opioid patches other tha as directed Talk to your healthcare provider if you have ay questios ad to esure that your opioid medicie is right for you * See page 11 for a list of some exteded-release ad log-actig opioid pai medicies. 3 4

Uderstadig the Risk of Abuse Opioid pai medicies ca be a target for people who abuse prescriptio medicies or street drugs. 1, 2, 3 Keep your opioid pai medicie i a safe place to prevet abuse or theft, 1 especially by people you live or work with or who come ito your home or workplace. Most people, icludig childre, who abuse opioid pai medicies get them from frieds or family members. 8 Quick Facts More tha 30 millio Americas aged 12 years or older report havig used prescriptio opioids omedically i their lifetime. More tha 2 millio people 12 years ad older begi abusig prescriptio opioids every year 8 Idividuals aged 12 ad older who abuse prescriptio opioids report that the majority of the time they obtai the drug from a fried or relative either for free, by purchasig it, or by stealig it 8 A recet survey of teeagers, grades 7-12, foud that 40% of all tees believe prescriptio medicies, eve if they are ot prescribed by a doctor, are safer to use tha illegal drugs. 1 i 3 tees believes that prescriptio pai relievers are ot addictive 9 Idividuals with problems with other drugs like alcohol or marijuaa are more likely to abuse prescriptio opioid pai medicie Tips to Prevet Abuse Keep your opioid pai medicie i a safe place to prevet abuse or theft 3 especially by people you live or work with or who come ito your home or workplace Keep opioid pai medicies i a safe place away from childre ad from ayoe for whom they have ot bee prescribed Properly dispose of your opioid pai medicie as soo as it is o loger eeded 6, 7 (see Safe Disposal, p. 10) Discuss your home eviromet with your healthcare provider to evaluate your home for risk factors for abuse ad overdose Tell your healthcare provider if you are cocered that someoe close to you at home or at work may steal or use your medicie Evaluate Your Home for Evirometal Risk Factors for Abuse ad Overdose Presece of youg childre Presece of adolescets or youg adults Presece of ay perso, icludig frieds, relatives, or stragers, who may have -- A history of substace abuse or addictio (eg, alcohol, marijuaa) -- A history of drug-seekig behaviors Metal health issues such as depressio or axiety Improper medicie hadlig, storage, or disposal (see How to Protect Yourself ad Your Family, p. 9) 5 6

Uderstadig the Risk of Addictio Addictio is a disease i which people crave or caot cotrol use of a drug, or cotiue usig a drug eve though they kow it is ot good for them. 10 Addictio does ot ofte develop whe takig opioid pai medicie as prescribed uder the guidace of a healthcare provider, 11 1, 2, 3 but it ca occur. The chace of abuse or addictio is greater if you are, or have ever bee, addicted to or have abused other medicies, street drugs, or alcohol, or if you have a history of metal problems. 1, 2, 3 Talk with your healthcare provider about your risk of addictio. You may develop a physical depedece to your opioid pai medicie, but that is ot the same as addictio. 1, 2, 10, 12 Physical depedece meas that if you suddely stop takig your medicie you may become sick because your body has gotte used to it. 10 Physical depedece is ot the same as addictio. Sometimes patiets with pai take matters ito their ow hads by takig more tha their prescribed amout of medicatio without prior approval from their healthcare provider. Takig more tha your prescribed amout of medicatio to treat your pai is ot the same as addictio, however, it ca be very dagerous. You should ever icrease your dose uless directed by your healthcare provider. Talk with your healthcare provider about your pai if you feel that you are ot gettig eough relief. Talkig With Your Healthcare Provider To esure that your opioid pai medicie is right for you, talk with your healthcare provider about the followig: Your complete medical ad family history, icludig ay history of substace abuse or metal illess The cause, severity, ad ature of your pai Your treatmet goals All medicies you take, icludig prescriptio ad over-the-couter (oprescriptio) medicies, vitamis, ad dietary supplemets Ay side effects or adverse evets you may be havig A cocer that someoe close to you at home or at work may steal or use your medicie Chages i your evirometal risk factors Use the My Meds Card at the back of this brochure to keep a record of all your medicatios, ad take the card with you wheever you see your healthcare provider or pharmacist. My Meds Card Name: Phoe #: My Pai Doctor: Phoe #: This card is provided as a importat aid i esurig that your opioid pai medicie is right for you. You should carry this card with you every time you see your My Pharmacy: Phoe #: healthcare provider or pharmacist. How Much Date Drug Name Dose Why I Take It pills / day Take this card with you every time you see your pharmacist. Record all of your medicatios i the space provided Never opt out of pharmacy couselig Read the Medicatio Guide you get with every opioid pai medicie prescriptio Copyright 2010 All rights reserved. 1. To make sure your pai medicie is right for you, tell your doctor Your complete medical ad family history, icludig ay history of substace abuse or metal illess The cause, severity, ad ature of your pai Your treatmet goals All medicatios you take, icludig over-the-couter (o-prescriptio) medicies, vitamis, ad dietary supplemets Ay side effects you may be havig Chages i your home eviromet 2. Take your opioid pai medicie with you to every office visit 3. Take your opioid pai medicie exactly as prescribed by your health care provider Take this card with you every time you see your healthcare provider. 7 8

How to Protect Yourself ad Your Family You are resposible for usig your opioid pai medicie safely ad keepig it away from family members, frieds, household acquaitaces, ad ayoe else who does ot have a prescriptio. Follow the steps below to protect yourself ad your family: Keep Away From Childre Store opioid pai medicies i a child-proof cotaier 6 Never trasfer your opioid pai medicie ito a ucotrolled cotaier like a daily pill remider 6 Keep Away From Others Protect From Theft Protect your opioid pai medicie from theft at all times 1 Always keep your opioid pai medicie secured or locked ad out of reach of childre 6 Keep a regular cout of the umber of remaiig pills Safe Disposal Properly dispose of your opioid pai medicie as soo as you ad your healthcare provider decide you o loger eed it 6, 7 To dispose of uused oral opioid pai medicie, remove the medicie from, 6, 17 the bottle or package ad flush it dow the toilet To dispose of fetayl trasdermal patches, ope the uused patches, fold the sticky sides of the patches together ad flush them dow the toilet 5 6 Limit access to your opioid pai medicie to yourself or your caregiver oly Do ot share your opioid pai medicie with someoe else, eve if they have the same symptoms as you Never sell or give away your opioid pai medicie to ayoe. It is agaist the law ad it may harm them 9 10

Examples of Exteded-Release ad Log-Actig Opioids Exteded-release ad log-actig opioids are opioid pai medicies that usually work for 8-24 hours. These medicies are typically for patiets who experiece pai cotiuously throughout the day (aroud the clock). Braded Products Trade Name Geeric Name Duragesic Fetayl Trasdermal System Yes EXALGO Dolophie Methadose Embeda Hydromorphoe HCI Exteded-Release Tablets Methadoe HCl Tablets Methadoe HCl Tablets Morphie Sulfate + Naltrexoe HCI Exteded- Release Capsules Aviza Morphie Sulfate Exteded-Release Capsules Yes Kadia Morphie Sulfate Exteded-Release Capsules Yes MS Coti Morphie Sulfate Cotrolled-Release Tablets Yes Oramorph Morphie Sulfate Sustaied-Release Tablets Yes OxyCoti Oxycodoe HCI Exteded-Release Tablets Yes Opaa ER Oxymorphoe Exteded-Release Tablets No Data accurate as of 8/18/2010. Geeric Available No Yes Yes No Glossary of Importat Terms Abuse: Use of a medicatio for a omedical purpose such as alterig oe s state of cosciousess (ie, gettig high). Acute Pai: A ormal sesatio triggered i the ervous system to alert you to possible ijury ad the eed to take care of yourself. 18 Addictio: A disease i which people crave or caot cotrol use of a drug, or cotiue usig a drug eve though they kow it is ot good for them. 10 Aroud-the-Clock Opioid Pai Medicie: Opioid pai medicie (usually exteded-release opioids) take regularly throughout the day (aroud the clock) to provide cotiuous pai relief. 14 Breakthrough Pai: A sudde, brief flare of moderate-to-severe pai that breaks through the relief provided by aroud-the-clock opioid pai medicie. 15 Chroic Pai: Pai that lasts for more tha 3 moths. Exteded-Release ad Log-Actig Opioids: Opioid pai medicies for patiets who experiece chroic pai cotiuously throughout the day (aroud the clock). These medicies usually work for 8 24 hours. Misuse: Use of a medicatio prescribed for a legitimate medical purpose i ways other tha as directed or idicated. Opioid: A kid of medicatio that is ofte used to treat pai. Opioids are very strog medicies that are dagerous if used i ways other tha as directed or by people who do ot have a prescriptio. Opioid Tolerace: A chage i your body from takig opioid pai medicie for a period of time, causig oe or more effects of the medicie to be reduced. 10 For example, tolerace may mea you have to take more opioid pai medicie to get the same pai relief. Tolerace is ot the same as addictio. 10 Overdose: A life-threateig state that occurs whe a perso takes more of a medicatio tha his or her body ca hadle. Physical Depedece: A coditio i which you become sick if you suddely stop takig your opioid pai medicie because your body has gotte used to it. 10 Physical depedece is ot the same as addictio. 10 Pseudoaddictio: Drug-seekig behavior that appears similar to addictio but is due to a eed for more medicatio to cotrol pai rather tha addictio. Short-Actig / Normal Release Opioid: A kid of medicie that usually works for about 2 to 6 hours. 11 12

Refereces: 1. EXALGO Medicatio Guide. Hazelwood, MO: Mallickrodt Brad Pharmaceuticals; 2010. 2. EMBEDA Medicatio Guide. Bristol, TN: Kig Pharmaceuticals, Ic.; 2009. 3. OxyCoti Medicatio Guide. Stamford, CT: Purdue Pharma LP; 2009. 4. US Ceter for Disease Cotrol Issue Brief: Uitetioal Drug Poisoig i the Uited States. http://www.cdc.gov/homeadrecreatioalsafety/poisoig/brief_full_page.htm. Accessed July 27, 2010. 5. Duragesic Medicatio Guide. Rarita, NJ: Ortho-McNeil-Jasse Pharmaceuticals, Ic.; 2009. [5] 6. FENTORA Medicatio Guide. Frazer, PA: Cephalo Ic.; 2007. 7. ONSOLIS Medicatio Guide. Somerset, NJ: Meda Pharmaceuticals Ic.; 2009. 8. US Departmet of Health ad Huma Services. Substace Abuse ad Metal Health Services Admiistratio. Results from the 2008 Natioal Survey o Drug Use ad Health: atioal fidigs. http://www.oas.samhsa.gov/sduh/2k8sduh/2k8results.pdf. Accessed May 23, 2010. 9. Partership for A Drug-Free America. Partership Attitude Trackig Study [PATs]. 2006. http://www.drugfree.org/files/full_ tee_report. Accessed Jue 17, 2010. 10. America Academy of Pai Medicie, America Pai Society, America Society of Addictio Medicie. Defiitios related to the use of opioids for the treatmet of pai. http://www.paimed.org/pdf/defiitio.pdf. Accessed May 23, 2010. 11. Flemig MF, Balousek SL, Klessig CL, Mudt MP, Brow DD. Substace use disorders i a primary care sample receivig daily opioid therapy. J Pai. 2007;8(7):573 582. 12. Fishma SM. Resposible opioid prescribig: A physicia s guide. Washigto, DC: Waterford Life Scieces; 2007. 13. Natioal Pharmaceutical Coucil. Pai: Curret uderstadig of assessmet, maagemet ad treatmets. 2001. http://www.pcow.org/public/ Research Publicatios/Publicatios/pub_rel_research/pub_quality_care/Pai Curret_ Uderstadig_of_Assessmet Maagemet ad_treatmets.aspx. Accessed May 3, 2010. 14. Simo S. Opioids ad treatmet of chroic pai: uderstadig pai patters ad the role for rapid-oset opioids. MedGeMed. 2005 Nov 23;7(4):54. 15. Porteoy RK, Hage NA. Breakthrough pai: defiitio ad maifestatios. Primary Care Cacer. 1991 April;27 28,33. 16. America Pai Society. Pediatric chroic pai. http://www.ampaisoc. org/advocacy/pediatric.htm. Accessed Jue 15, 2010. 17. http://www.fda.gov/drugs/ ResourcesForYou/Cosumers/BuyigUsigMedicieSafely. Accessed Jue 30, 2010. 18. The America Academy of Pai Maagemet. Facts ad Figures o Pai. http://www.paimed.org/patiet/facts.html#pai. Accessed Jue 30, 2010. 13 14

Safe Use ad Hadlig Card The card below is a importat remider of what you should do to keep yourself, your family, ad others safe while you are takig opioid pai medicie. Tear or cut the card out alog the dotted lie ad keep it for quick referece. Tear Out Alog Edge This card cotais importat remiders to help esure the safe use, hadlig, ad disposal of your opioid pai medicie. DO Read the Medicatio Guide Take exactly as prescribed Take exactly as it was give to you Call 911 i case of accidetal use or overdose Copyright 2010 All rights reserved. DO NOT Do ot take with alcohol Do ot take with medicies that make you sleepy Do ot drive uless safe to do so Safe Use ad Hadlig Card Tear Out Alog Edge My Meds Card You are resposible for keepig your opioid pai medicie away from ayoe who could be harmed by usig it iappropriately or takig it accidetally. Follow these steps to protect yourself ad others: Keep away from childre Keep away from others Keep i a safe, secure place, protect from theft Dispose of properly My Meds Card Complete the My Meds Card below, tear or cut out the card alog the dotted lie, ad keep it i your wallet for hady referece wheever you see your healthcare provider or pharmacist. FOLD Tear Out Alog Edge My Meds Card Name: Phoe #: My Pai Doctor: Phoe #: My Pharmacy: Phoe #: Date Drug Name Dose How Much (pills / day) Why I Take It FOLD FOLD Tear Out Alog Edge This card is provided as a importat aid i esurig that your opioid pai medicie is right for you. You should carry this card with you every time you see your healthcare provider or pharmacist. Take this card with you every time you see your pharmacist. Record all of your medicatios i the space provided Never opt out of pharmacy couselig Read the Medicatio Guide you get with every opioid pai medicie prescriptio 2. Take your opioid pai medicie with you to every office visit Take this card with you every time you see your healthcare provider. 1. To make sure your pai medicie is right for you, tell your doctor Your complete medical ad family history, icludig ay history of substace abuse or metal illess The cause, severity, ad ature of your pai Chages i your home eviromet Ay side effects you may be havig All medicatios you take, icludig over-the-couter (o-prescriptio) medicies, vitamis, ad dietary supplemets Your treatmet goals FOLD Copyright 2010 All rights reserved. 15 16